Determination of Amlodipine besylate tablets (2.5/5mg) by HPLC method

1.0 OBJECTIVE                    

To provide the procedure for the determination of Amlodipine besylate tablets (2.5/5mg) by HPLC method

2.0 SCOPE

This procedure is Applicable to the determination of Amlodipine besylate tablets (2.5/5mg)

3.0 RESPONSIBILITY 

3.1 QC-Chemist 

4.0 ACCOUNTABILITY         

4.1 Executive – Quality control

4.2 Head – Quality control

5.0 PROCEDURE    

      

5.1 Mobile Phase:

750 ml methanol: 230ml acetonitrile: 20 ml 0.01M ortho phosphoric acid (OPA) adjust the pH to 5.8 with OPA

5.2 Standard and sample Preparation:

Weigh accurately about 100mg of Amlodipine besylate working standard in a 100ml volumetric flask and dissolve and dilute to 100 ml with mobile Phase.

Dilute 10ml of the above solution in to 100 ml with dilute with mobile phase upto the mark.

5.3 Sample Preparation:

Weight powder twenty tablets and take the powder equivalent to 100mg Amlodipine besylate was accurately weighed, dissolve dilute to 100ml with mobile Phase, filtered through Whatmann filter paper No: 41.

Dilute 10ml of the above solution in to 100 ml with dilute with mobile phase upto the mark.

5.4 Chromatographic conditions:

Mode	Isocratic
Flow rate	1.0ml / minute
Wavelength	236nm
Injection volume	20µL
Column	C18, 250*4.6*5µm
Run Time	8 minutes

 5.5 Retention Time:

Amlodipine besylate: 3.0 min

Equivalent factor : 1.388 in calculation 

6.0 ANNEXURES

Nil

Calculation: